US8366733B2 - Applicator instruments for controlling bleeding at surgical sites and methods therefor - Google Patents

Abstract

An instrument for controlling bleeding includes an outer shaft having a central lumen extending between proximal and distal ends thereof, and an inner shaft disposed within the central lumen of the outer shaft, the inner shaft having a central lumen extending between proximal and distal ends thereof. The instrument has an inflatable balloon with a proximal end secured to the outer shaft and a distal end that is inverted and secured to the inner shaft. In one embodiment, the balloon has a spherical shape when the outer and inner shafts are in a first position and a toroidal shape when the outer and inner shafts are in a second position. The instrument includes an actuator for discharging a flowable material from the central lumen. In one embodiment, the instrument includes a stylet having barb-like features to attach a hemostat to the distal end of the instrument.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is related to commonly assigned U.S. patent application Ser. No. 12/049,849, entitled “APPLICATOR INSTRUMENTS FOR THE DELIVERY, DEPLOYMENT, AND TAMPONADE OF HEMOSTATS AND METHODS THEREFOR,” filed Mar. 17, 2008, and U.S. patent application Ser. No. 12/049,869, entitled “APPLICATOR INSTRUMENTS HAVING PROTECTIVE CARRIERS FOR HEMOSTATS AND METHODS THEREFOR,” filed Mar. 17, 2008, the disclosures of which are hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present application is generally related to controlling bleeding, and is more specifically related to systems, instruments, and methods used for the delivery, deployment, and tamponade of hemostats and flowable hemostats and sealants used for controlling bleeding at surgical sites.

2. Description of the Related Art

Medical textiles are used during surgical procedures to control bleeding, minimize blood loss, reduce post-surgical complications, and shorten the duration of surgery. Commonly used medical textiles include adhesion barriers, sponges, meshes, and hemostatic wound dressings that are applied to the surface of tissue. Hemostatic wound dressings include absorbable hemostats such as those sold by Ethicon, Inc. of Somerville, N.J. under the registered trademarks Surgicel®, Surgicel Nu-Knit®, and Surgicel® Fibrillar.

Traditionally, medical textiles have been delivered to endoscopic surgical sites using endoscopic grasping instruments such as clamps and forceps. It is also well-known to use applicator instruments for delivering medical textiles. For example, U.S. Pat. No. 3,857,395 discloses an inserter device having a pair of outwardly bendable arms that bilaterally spread an adhesion barrier within a vaginal cavity. The inserter device disclosed in the '395 patent, however, is not suitable for insertion through an endoscopic tube or trocar.

Commonly assigned U.S. Pat. No. 5,395,383 discloses an applicator instrument used for applying a sheet of surgical material (i.e. an adhesion barrier) through an endoscopic tube. The applicator instrument includes an expandable operating tip that is insertable into an endoscopic tube to enable a surgeon to apply the surgical material to tissue inside a body. In one embodiment, the applicator comprises a set of telescoping tubes including an outer delivery tube, an intermediate deployment tube, and an inner irrigation tube. The expandable operating tip is mounted at the distal end of the irrigation tube and is connected to the distal end of the deployment tube. The spreader tip is exposed at the distal end of the delivery tube by advancing the deployment tube and the irrigation tube relative to the delivery tube. The spreader tip is expanded by movement of the deployment tube relative to the irrigation tube to spread the sheet of surgical material over the tissue. A nozzle is provided at the distal end of the irrigation tube for applying a fluid, e.g., a saline solution, to the surgical material.

Commonly assigned U.S. Pat. No. 5,397,332 discloses an applicator for applying a sheet of surgical material, e.g., a surgical mesh, to internal body tissue. The applicator includes a delivery tube, a deployment tube slidably received within the delivery tube, and a shaft or irrigation tube slidably received within the deployment tube. An expandable spreader tip is connected between the distal ends of the shaft and the deployment tube. The spreader tip is collapsed and inserted in the delivery tube with the surgical mesh. The applicator is inserted through a trocar tube into a body cavity and the spreader tip is exposed by retracting the delivery tube relative to the deployment tube and shaft. The applicator has a first actuator for urging the spreader tip and surgical mesh into engagement with the tissue as the deployment tube is retracted, and a second actuator for advancing the deployment tube relative to the shaft to expand the spreader tip to apply the surgical mesh to the tissue. The spreader tip includes a plurality of flexible strips each having opposite ends pivotally connected to the distal ends of the shaft and the deployment tube. The applicator includes a return spring to bias the deployment tube proximally relative to the shaft to normally maintain the spreader tip in a collapsed configuration.

In spite of the above advances, there remains a need for improved instruments and methods for the delivery, accurate placement, deployment, and tamponade of medical textiles such as adhesion barriers, wound dressings, and topically applied hemostats. More particularly,

In addition, there remains a need for instruments and methods for introducing flowable hemostats and sealants to surgical sites for controlling bleeding.

SUMMARY OF THE INVENTION

In one embodiment, the present invention discloses an applicator instrument used for the endoscopic delivery of medical textiles such as meshes, hemostats, adhesion prevention barriers, and sponges, and flowable materials such as flowable hemostats and sealants. In one embodiment, the applicator instrument is preferably adapted for the endoscopic delivery, deployment and tamponade of hemostats such as topically applied hemostats (TAH), and flowable hemostats. In the present application, the terms “hemostat”, “topically applied hemostat”, and “flowable hemostat” are used most frequently to describe the various medical components that may be delivered and deployed by the present invention. However, the present application contemplates that these terms should be read broadly to cover all of the medical textiles and flowable hemostats and sealants described, as well as other materials conventionally used to control bleeding.

In one embodiment, an instrument for controlling bleeding includes an outer shaft having a proximal end, a distal end, and a central lumen extending between the proximal and distal ends, and an inner shaft disposed within the central lumen of the outer shaft, the inner shaft having a proximal end, a distal end that extends beyond the distal end of the outer shaft, and a central lumen extending between the proximal and distal ends thereof. The instrument desirably includes an inflatable balloon having a proximal end secured to the outer shaft and a distal end that is inverted and secured to the inner shaft, and a first actuator in communication with the inflatable balloon for selectively inflating the balloon. In one embodiment, the first actuator includes a syringe having a barrel and a plunger, and the plunger is depressible for introducing the fluid into the balloon. The instrument preferably has a first conduit extending between the inner and outer shafts and toward the distal ends of the inner and outer shafts. The first conduit is desirably in communication with the inflatable balloon at one end, and the first actuator at an opposite end of the first conduit.

In one embodiment, the instrument includes a hub connector secured to the proximal end of the outer shaft. The hub connector desirably has a first connection port for coupling the first actuator with the first conduit. The hub connector may also have a second connection port that is aligned with the central lumen of the inner shaft. A stylet may be inserted into the second connection port and the central lumen of the inner shaft. The stylet may have proximal and distal ends, a handle at the proximal end thereof, and hook-like barbs at the distal end thereof. The stylet is preferably insertable into the second connection port and through the central lumen of the inner shaft for positioning the hook-like barbs at the distal end of the inner shaft. The stylet may also have threads adjacent the handle thereof for threadably securing the stylet to the hub connector.

In one embodiment, the instrument may include a second actuator adapted to hold a flowable material, such as a flowable hemostat material or a sealant. The second actuator may be coupled with the second connection port of the hub connector for dispensing the flowable material through the central lumen of the inner shaft. In one embodiment, the second actuator includes a barrel for holding the flowable material, a discharge opening alignable with the central lumen of the inner shaft, and a plunger that is depressible for dispensing the flowable material into the central lumen of the inner shaft. The second actuator may include a connector such as a Luer connector for securing the tip of the second actuator to the second connection port of the hub connector. In one embodiment, the second actuator may include a sealant delivery system having a catheter that extends through the central lumen of the inner shaft for delivering the sealant from the distal end of the instrument. One preferred sealant delivery system may include the Evicel™ sealant delivery system sold by Johnson & Johnson Wound Management of New Brunswick, N.J. A preferred sealant delivery system may have a catheter tip having a length of up to 35 cm or more in length, whereby the catheter tip is passed through the central lumen of the inner shaft to deliver the sealant from the distal end of the instrument.

In one embodiment, the instrument may include a shaft actuator in communication with at least one of the inner and outer shafts for selectively moving the distal ends of the shafts relative to one another for changing the shape of the inflated balloon. In one preferred embodiment, the shaft actuator is adapted to selectively move the distal end of the outer shaft in a distal direction relative to the distal end of the inner shaft for changing the shape of the inflatable balloon secured to the outer and inner shafts. When desired, the outer shaft may be moved proximally back to its original configuration for transforming the shape of the inflated balloon back to the original spherical shape.

In one embodiment, an instrument for controlling bleeding includes a shaft having a proximal end and a distal end, an inflatable balloon having a proximal end secured to the shaft and a distal end that is inverted and that is secured to the distal end of the shaft. The inverted distal end of the inflatable balloon is desirably connected to a distal-most end of the shaft. The instrument also preferably includes an actuator for selectively inflating the inflatable balloon. The actuator is desirably coupled with a connection port located at the proximal end of the shaft. The instrument may include a valve in communication with the inflatable balloon for selectively deflating the balloon. In one embodiment, the instrument includes barbs projecting from the distal end of the shaft. The shaft desirably has a longitudinal axis extending between the proximal and distal ends thereof, and the barbs project along the longitudinal axis.

In one embodiment, an instrument for controlling bleeding includes an inner shaft having a proximal end and a distal end, and an outer shaft having a proximal end and a distal end, the outer shaft surrounding the inner shaft. The instrument includes a first lumen extending between the inner and outer shafts, and a second lumen extending though the inner shaft to a distal opening at the distal end of the inner shaft. The instrument also desirably includes an inflatable balloon secured to the distal end of the instrument, the inflatable balloon being in communication with the first lumen. The balloon preferably has a proximal end secured to the outer shaft and a distal end surrounding the distal opening of the second lumen and being secured to the inner shaft. In one embodiment, the distal end of the balloon is inverted and the inverted distal end of the balloon is secured to the distal end of the inner shaft.

The instrument may also include a first actuator, such as an inflation syringe, in communication with the first lumen for selectively inflating the balloon, and a second actuator, such as a syringe filled with a flowable material, in communication with the second lumen for introducing the flowable material into the second lumen and for discharging the flowable material from the distal opening at the distal end of the inner shaft. The flowable material may be a sealant and/or a flowable hemostat material.

The instrument may include a hub connector secured to the proximal end of the outer shaft. The hub connector desirably has a first connection port in communication with the first lumen. The hub connector may also have a second connection port in communication with the second lumen. The first actuator is preferably coupled with the first connection port and the second actuator is preferably coupled with the second connection port. The instrument may also include a third actuator coupled with the outer shaft for moving the distal end of the outer shaft distally relative to the distal end of the inner shaft for selectively changing the shape of the inflatable balloon.

In one embodiment, the applicator instrument includes a balloon that is used to endoscopically deploy and tamponade a hemostat. The balloon is desirably attached at each end to one of two pieces of concentric tubing such that one balloon end is movable and the shape of the inflated balloon is changeable from a rounder shape to a flatter shape, such as from a spherical shape to a toroidal shape. In one embodiment, the distal end of the balloon is inverted and the inverted surface is attached to the outer surface of one of the concentric tubes so that when the balloon is inflated the attachment of the distal end of the balloon to the distal end of the device is located inside the inflated balloon. This configuration provides a flatter surface area of the balloon for applying an evenly distributed tamponade pressure to the hemostat.

In one embodiment, barbed hooks may be incorporated at the distal end of the applicator instrument, and the hooks or barbs may be used to attach the hemostat to the distal end of the instrument prior to delivering the hemostat to a surgical site.

In one embodiment, the outer and inner shafts may be moved relative to one another for changing the shape of the inflated balloon. In one embodiment, the balloon has a rounder or more spherical shape when the outer and inner shafts are in a first position and a flatter or more toroidal shape when the outer and inner shafts are in a second position. In one embodiment, the balloon assumes a toroidal shape, and the flattened leading face of the balloon is used to apply tamponade pressure to one or more hemostats.

The applicator instrument may include a hemostat disposed at the distal end of the inner shaft. The hemostat may be a medical textile, a topically applied adhesive, a hemostat patch folded over the distal end of the inner shaft, a flowable hemostat, or any conventional medical device used to control bleeding. The inner shaft may have barbs or hooks provided at the distal end thereof for attaching a hemostat such as a topically applied hemostat or a hemostat patch to the inner shaft.

In one embodiment, the instrument includes a first actuator for selectively inflating the balloon, and another actuator coupled with at least one of the outer and inner shafts for selectively moving the distal ends of the outer and inner shafts relative to one another for changing the shape of an inflated balloon. In one embodiment, the outer and inner shafts desirably have tubular shapes, and at least one of the outer and inner shafts has an opening for introducing fluid, such as air, into the balloon.

In one embodiment of the present invention, a method for controlling bleeding includes providing an applicator instrument, and attaching a hemostat to the distal end of the instrument. The applicator instrument with the hemostat attached thereto may be advanced to a surgical site such as by passing the tip of the applicator instrument through an endoscope or trocar. After the hemostat has been delivered to the surgical site, a balloon at the distal end of the applicator instrument may be inflated by engaging an actuator such as a syringe plunger. As the balloon is inflated, the expanding balloon deploys the hemostat by unfurling the hemostat and advancing the edges of the hemostat toward the tissue surface at the surgical site. When the balloon is inflated, it normally assumes a substantially spherical shape. The shape of the balloon may be changed, however, by engaging another actuator such as a deformation slider that changes the shape of the balloon into a substantially toroidal shape. In the toroidal shape, a leading face of the balloon now assumes a substantially flatter surface that provides more surface area for engaging the delivered and deployed hemostat. In one embodiment, tamponade pressure is applied by the balloon to the hemostat for approximately 1-5 minutes, and more preferably 2-3 minutes.

In one embodiment, the inflatable balloon is transparent so that the deployment and tamponade of the hemostat may be observed through the balloon. If bleeding has not been controlled after a predetermined period of time, this condition may be observed through the transparent balloon. In response to this condition, tamponade pressure may be applied for longer time periods until the bleeding has stopped or is under control.

In one embodiment, after the bleeding is under control, the deformation slider may be retracted for returning the intermediate and inner shafts to the normal spacing configuration. As the deformation slider is retracted, the balloon is preferably transformed from a toroidal shape back to the original spherical shape. The inflated balloon may be deflated by retracting the plunger of the balloon inflation actuator. A spring provided inside the syringe may return the plunger to the retracted position. After the balloon is deflated, the tip of the applicator instrument may be retracted from the surgical site and removed from the endoscope or trocar. After the applicator instrument is withdrawn from the surgical site, the hemostat preferably remains in place atop the tissue at the surgical site for controlling bleeding.

Although the present invention is not limited by any particular theory of operation, it is believed that the present invention provides numerous benefits over prior art instruments, systems, and methods. One advantage of the present invention is that the shape of an inflated balloon may be altered so as to maximize the surface area available for applying tamponade pressure to a deployed hemostat. The increased surface area and the flatter surface area allows for more efficient and enhanced tamponade pressure to be applied to the hemostats. This feature is particularly useful for applying pressure to topically applied hemostats.

In addition, in one embodiment, the present invention discloses an applicator instrument having a transparent balloon that enables medical personnel to observe a surgical site as tamponade pressure is applied to hemostats using the balloon.

In one embodiment, the outer and inner shafts of the applicator instrument are not moveable, and the balloon does not change shape. After the balloon is inflated to a desired shape, either spherical or toroidal as described earlier, the fluid used to inflate the balloon is communicated between the outer diameter (OD) of the inner shaft and the inner diameter (ID) of the outer shaft. The lumen of the inner shaft may be in communication through the proximal handle of the device. The proximal end of the inner shaft may have a syringe connector means, such as a Luer connector, attached thereto. The Luer connector may be used to attach a syringe that dispenses a fluid (e.g. SURGIFLO) through the lumen of the inner shaft into a surgical cavity, with the balloon in either an inflated or deflated state. The lumen of the inner shaft may also be used to guide, support and allow passage of other fluid delivery systems, such as the EVICEL Fibrin Sealant having a 45 cm catheter delivery device. Moreover, a Luer cap or plug may be attached to the Luer connector to prevent surgical cavity insufflation gases from undesirably exiting through the instrument. In one embodiment, a stylet may be passed through and attached to the Luer connector. The stylet preferably has a length such that the tip of the stylet is in close proximity to the distal end of the lumen of the inner shaft. The distal tip of the stylet may have barbs, for the purpose of engaging and picking up and a textile based topically applied hemostat (TAH) as described herein.

In one embodiment, the applicator instrument may have only a single shaft, and the balloon may not change shape after it is inflated. In one embodiment, both the distal and proximal ends of the inflatable balloon are attached to the outer diameter (OD) of a single shaft. The proximal end of the shaft may have a hub connector secured thereto. A syringe having a flowable hemostat may be coupled to the hub connector for dispensing a flowable hemostat through a central lumen of the shaft.

In one embodiment, a user may physically hold the balloon inflation syringe plunger in the depressed position in order to keep the balloon inflated. The user may pull back on the syringe plunger to deflate or aspirate the balloon, or the syringe may have an axially aligned internal spring that is adapted to return the plunger to the extended position for automatically aspirating the balloon. In one embodiment, the spring may be axially aligned and be located between the proximal surface of the barrel's flange and the distal surface of the plunger's proximal flange.

In one embodiment, the syringe includes a locking ring that engages the outer surface of a cylindrical plunger to lock the plunger in place. When it is desired to move the plunger, the locking ring may be pushed toward the leading end of the syringe to release the plunger for movement. This embodiment may incorporate one or more of the features or method steps disclosed in commonly assigned U.S. patent application Ser. No. 12/049,849, entitled “APPLICATOR INSTRUMENTS FOR THE DELIVERY, DEPLOYMENT, AND TAMPONADE OF HEMOSTATS AND METHODS THEREFOR, filed Mar. 17, 2008, the disclosure of which is hereby incorporated by reference herein.

In one embodiment, the syringe plunger is adapted to be locked at discrete axial intervals. In this embodiment, a series of slots are cut into the plunger's cruciform cross section, and a distally mounted disk-like cap is fixed to the flange end of the barrel. The disk-like cap has a cruciform slot cut out to allow passage of the plunger's cruciform cross section. By rotating the plunger about (nominally) 45 degrees along its long axis when a set of slots in the plunger line up with the cruciform slot in the disk, the plunger cannot be moved axially due to either proximal or distal surfaces of the plunger's slots making contact with the portions of the disk adjacent to the cruciform slot. To unlock the plunger for balloon aspiration, the plunger is rotated so that the cruciform cross-section part of the plunger is in line with the cruciform slot in the disk.

In one embodiment, a valve system is placed between the syringe and the balloon inflation port. The valve system may include a two port stopcock; a three port stopcock, one port venting to the outside when not shut off; a Luer-activated valve (normally closed, opens when a syringe male Luer fitting is introduced into the valve); a check-valve (e.g. a duckbill or disk valve in a housing); or a system including a check valve that is bypassed by a normally closed trumpet valve, a two port stopcock, or a three port stopcock. The valve system may be removable from the handle, or it may be integrated into the handle. The valve system may also be mounted to a short piece of extension tubing either between the valve system and the handle or between the valve system and the syringe. One advantage of these systems is that the syringe may be inflated to any volume, not just discrete intervals. Another advantage of the systems having the three port stopcock configurations is that the balloon inflation path may be vented to the outside without removing the inflation syringe, which may be operationally advantageous if fluid such as air needs to be added or removed from the normally sealed balloon inflation path.

These and other preferred embodiments of the present invention will be described in more detail below.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 shows a front elevational view of an instrument for controlling bleeding including a proximal end having a hub connector and a distal end having an inflatable balloon, in accordance with one embodiment of the invention.

FIG. 2 shows a cross-sectional view of the hub connector shown inFIG. 1.

FIG. 3 shows a cross-sectional view of the inflatable balloon at the distal end of the instrument shown inFIG. 1.

FIGS. 4A-4C show a stylet used with the instrument ofFIG. 1.

FIG. 5A shows a front elevational view of the instrument ofFIG. 1 after the stylet ofFIGS. 4A-4C has been into the hub connector and advanced toward the distal end of the instrument.

FIG. 5B shows a cross-sectional view of the hub connector after the stylet has been inserted into the hub connector.

FIG. 6A shows a front elevational view of the distal end of the instrument shown inFIG. 5A.

FIG. 6B shows a cross-sectional view of the distal end of the instrument shown inFIG. 6A.

FIGS. 7A-7B show the instrument ofFIG. 5A including an actuator for selectively inflating the inflatable balloon located at the distal end of the instrument.

FIGS. 8A-8B show the instrument ofFIGS. 7A-7B after the balloon has been inflated.

FIG. 9 shows a cross-sectional view of the distal end of the instrument ofFIG. 5A after the balloon has been inflated.

FIGS. 10A and 10B show perspective and phantom views, respectively, of a second actuator for an instrument for controlling bleeding, in accordance with one embodiment of the invention.

FIGS. 11A and 11B show front elevational and cross-sectional views, respectively, of the second actuator ofFIGS. 10A and 10B coupled with a hub connector of an instrument for controlling bleeding.

FIGS. 12A and 12B show front elevational and cross-sectional views, respectively, of an instrument for controlling bleeding with an inflatable balloon at a distal end of the instrument being in an inflated state.

FIGS. 13A and 13B show front elevational and cross-sectional views, respectively, of an instrument for controlling bleeding, in accordance with one embodiment of the present invention.

FIGS. 14A and 14B show front elevational and cross-sectional views, respectively, of an instrument for controlling bleeding, in accordance with one embodiment of the present invention.

FIG. 15 shows a front elevational view of an instrument for controlling bleeding including a hub connector at a proximal end and an inflatable balloon at a distal end, in accordance with one embodiment of the present invention.

FIGS. 16A and 16B show respective front elevational and cross-sectional views of the hub connector and the proximal end of the instrument shown inFIG. 15.

FIG. 17 shows a front elevational view of the instrument ofFIG. 15 having an actuator coupled with the hub connector at the proximal end.

FIG. 18 shows a cross-sectional view of the hub connector ofFIG. 15 with the actuator coupled therewith.

FIGS. 19A and 19B show respective front elevational and cross-sectional views of the inflatable balloon at the distal end of the instrument shown inFIG. 15.

FIG. 20 shows a cross-sectional view of the instrument ofFIG. 17A with the inflatable balloon in an inflated state.

FIG. 21 shows a cross-sectional view of the distal end of the instrument shown inFIG. 20.

FIGS. 22A and 22B show respective front elevational and cross-sectional views of a distal end of an instrument having an inflatable balloon for controlling bleeding, in accordance with one embodiment of the invention.

FIG. 23 shows the distal end of the instrument shown inFIG. 22B with the inflatable balloon in an inflated state.

FIG. 24 shows an instrument for controlling bleeding including a hub connector at a proximal end and an inflatable balloon at a distal end, in accordance with one embodiment of the invention.

FIG. 25 shows a cross-sectional view of the hub connector ofFIG. 24.

FIG. 26 shows a cross-sectional view of the instrument ofFIG. 24 with an actuator for inflating the balloon coupled with the hub connector.

FIG. 27 shows the instrument ofFIG. 26 with the inflatable balloon in an inflated state.

FIGS. 28A and 28B show cross-sectional views of a distal end of an instrument for controlling bleeding including an inflatable balloon, in accordance with one embodiment of the invention.

FIG. 29 shows the instrument ofFIGS. 28A and 28B after the inflatable balloon at the distal end has been inflated.

FIG. 30 shows the instrument ofFIG. 29 after the shape of the inflated balloon has been altered.

FIGS. 31A and 31B show cross-sectional views of a distal end of an instrument for controlling bleeding including an inflatable balloon, in accordance with one embodiment of the invention.

FIG. 32 shows the instrument ofFIGS. 31A and 31B after the inflatable balloon at the distal end has been inflated.

FIG. 33 shows the instrument ofFIG. 32 after the shape of the inflated balloon has been altered.

FIG. 34 shows a cross-sectional view of an instrument for controlling bleeding including an outer shaft that is movable relative to an inner shaft, in accordance with one embodiment of the present invention.

FIG. 35A shows the distal end of the instrument shown inFIG. 34 with the outer and inner shafts in a first position relative to one another.

FIG. 35B shows the distal end of the instrument shown inFIG. 34 with the outer and inner shafts in a second position relative to one another.

FIGS. 36A and 36B show front elevational views of an instrument for controlling bleeding, in accordance with one embodiment of the present invention.

FIGS. 37A and 37B show front elevational views of an instrument for controlling bleeding, in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION

The invention disclosed herein is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways.

The headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.

Referring toFIG. 1, in one embodiment, aninstrument100 for controlling bleeding has aproximal end102 and adistal end104. Theinstrument100 includes anouter shaft106 that extends between the proximal anddistal ends102 and104, ahub connector108 coupled with aproximal end110 of theouter shaft106, and aninflatable balloon112 connected with adistal end114 of theouter shaft106. In one embodiment, the length of the outer shaft106 (the “working length”) is about 10-15 inches, and more preferably about 13 inches (33 cm).

Referring toFIG. 2, in one embodiment, thehub connector108 includes ahousing116 having aleading end118 and a trailingend120. Theleading end118 of thehousing116 includes ashaft opening122 that is adapted to receive theouter shaft106 and aninner shaft124. Theouter shaft106 desirably has a central lumen that extends between the proximal and distal ends thereof, and theinner shaft124 is received within the central lumen of the outer shaft. In turn, theinner shaft124 has a central lumen that extends between the proximal and distal ends thereof. Thehub connector108 includes ashaft support tube126 having acentral bore128 that extends between aleading end130 and a trailingend132 of the shaft support tube. Thecentral bore128 has a leadingsection134 having a first inner diameter that closely matches the outer diameter of theouter shaft106, and a trailingsection136 having a second inner diameter that closely matches the outer diameter of theinner shaft124. In one embodiment, the leadingsection134 of thecentral bore128 has a larger diameter than the trailingsection136 of the central bore. Thecentral bore128 also desirably includes anintermediate section138 that lies between the leadingsection134 and the trailingsection136. Theintermediate section138 of thecentral bore128 is preferably in communication with afirst conduit140 that extends in a distal direction between theinner shaft124 and theouter shaft106.

Thehub connector108 desirably includes afirst connection port142 that is in communication with theintermediate section138 of thecentral bore128. Thefirst connection port142 desirably has a taperedopening143. A first actuator (not shown), such as a syringe, may be coupled with thefirst connection port138 for forcing a fluid such as air through theintermediate section138 of the central bore and into thefirst conduit140. The first actuator may have a tip having a taper that matches the taper of thetapered opening143. As will be described in more detail below, the fluid forced through the first conduit may be used for inflating theinflatable balloon112 located at the distal end of the instrument. The second connection port preferably hasthreads145 for connecting the first actuator to the first connection port.

Thehub connector108 also desirably includes asecond connection port144 such as a connection port including a female threaded Luer connection at the trailingend132 of theshaft support tube126.Threads146 are provided around the trailingend132 of theshaft support tube126 to provide a threaded coupling for an opposing element, as will be described in more detail below. Thesecond connection port144 preferably has a taperedopening147 that is adapted to receive the leading end of the second actuator. The leading end of the second actuator may have a taper that matches the taper of thetapered opening147.

Referring toFIG. 3, thedistal end104 of theinstrument100 includes theouter shaft106, theinner shaft124, and thefirst conduit140 that extends between the outer and inner shafts. Adistal end148 of the inner shaft preferably extends beyond thedistal end114 of theouter shaft106. The instrument includes theinflatable balloon112 having aproximal end150 secured to thedistal end114 of theouter shaft106, and adistal end152 that is secured to thedistal end148 of theinner shaft124. Theproximal end150 of theinflatable balloon112 is preferably secured to an outer surface of theouter shaft106. Thedistal end152 of theinflatable balloon112 is preferably inverted, and the inverted distal end is preferably secured to an outer surface of theinner shaft124 at the distal end of theinner shaft124. The above-described structure desirably forms an air-tight compartment154 inside theinflatable balloon112. Thedistal end156 of thefirst conduit140 is preferably in communication with the air-tight compartment154. Fluid such as air may be directed through thefirst conduit140 and into thecompartment154 for inflating theballoon112. When it is desirable to deflate theballoon112, the fluid may be removed from the balloon through thefirst conduit140. In the particular embodiment shown inFIGS. 1-3, the outer andinner shafts106,124 do not move relative to one another. In other embodiments, however, the outer and inner shafts may be selectively moved relative to one another for changing the shape of an inflated balloon. In one embodiment, the balloon initially has a spherical shape, and the outer and inner shafts are moved relative to one another to change the balloon into a more toroidal shape.

In one embodiment, theouter shaft106 has an outside diameter of about 0.2 inches, and a wall thickness of about 0.01 inches. Theinner shaft124 desirably has sufficient clearance to allow it to fit within the outer shaft. The wall thickness of theinner shaft124 is preferably about 0.01 inches. In embodiments where the shafts move relative to one another, the inner shaft has sufficient clearance to allow it to slide relative to the outer shaft.

In one embodiment, thedistal end152 of theballoon112 is attached or bonded over the distal 0.25 inches of theinner shaft124, and theproximal end150 of the balloon is attached or bonded over the distal 0.25 inches of theouter shaft106. Thedistal end152 of theballoon112 is inverted before it is attached to the outer surface of theinner shaft124. As a result, when the balloon is inflated, the attachment of the distal end of the balloon to the distal end of the instrument is located inside the inflated balloon.

In one embodiment, the proximal ends of the outer and inner shafts may be contained within a hub connector, a handle, or a housing that provides for easy manual control of the shafts for slidably moving the outer shaft forward relative to the inner shaft a distance of up to about 0.75 inches. The hub connector, handle, or housing may include an element for manually inflating and deflating the balloon. The hub connector, handle, or housing may resemble those of other trigger-operated endoscopic devices, such as the EES Proximate Stapler line or the Ethicon Morcellex device.

Referring toFIGS. 2 and 3, theinner shaft124 has acentral lumen160 that extends from thedistal end148 of the inner shaft to aproximal end162 of the inner shaft. In one embodiment, thecentral lumen160 is preferably aligned with thesecond connection port144 so that astylet164, as shown inFIGS. 4A-4C, may be inserted through the second connection port and into thecentral lumen160.

Referring toFIG. 4A, thestylet164 includes arod166 having aproximal end168 and adistal end170. Referring toFIG. 4B, thedistal end170 of the stylet includes aplug172 having anouter surface174 defining an outer diameter that closely matches an inner diameter of thecentral lumen160 of theinner shaft124. Thedistal end170 of thestylet164 also preferably includes hook-like barbs176 that project from the distal end. As will be described in more detail below, thebarbs176 are adapted to hold a hemostat, such as a hemostat patch, onto the distal end of thestylet164 during a surgical procedure. Referring toFIG. 4C, theproximal end168 of thestylet164 includes ahandle178 having a leadingface180, arim182 projecting from the leadingface180, andinternal threads184 provided inside therim182. Theproximal end168 of therod166 is secured to the leadingface180 of thehandle178 via atapered hub185 located inside therim182. In one embodiment, the taper angle of thetapered hub185 preferably matches the taper of the opening of the second connector port.

Referring toFIGS. 5A and 5B, in one embodiment, the distal end of thestylet164 is inserted into thesecond connection port144 of thehub connector108 and advanced toward thedistal end114 of the instrument until thebarbs176 protrude from the distal end of the inner shaft. Once the barbs are protruding from the distal end of the inner shaft, thetapered hub185 of the stylet preferably engages the tapered opening of thesecond connection port144. In addition, theinternal threads184 on therim182 of thehandle178 preferably engage theexternal threads146 around thesecond connection port144 for securing the proximal end of thestylet164 to the second connection port.

Referring toFIGS. 6A and 6B, after thestylet164 has been advanced to thedistal end148 of theinner shaft124, thebarbs176 desirably project from the distal end of theinstrument100. Referring toFIG. 6B, theouter surface174 of theplug172 engages the inner surface of theinner shaft124 to form a fluid-tight or air-tight seal at thedistal end148 of theinner shaft124. With the balloon in the deflated state shown inFIGS. 6A and 6B, thebarbs176 may be used to secure ahemostat200 to the distal end of theinstrument100. The distal end of the instrument may then be positioned at a surgical site for delivering thehemostat200 to the surgical site. Theballoon112 may then be inflated for decoupling the hemostat from thebarbs176, and pressing the hemostat onto tissue at the surgical site.

Referring toFIGS. 7A and 7B, in one embodiment, afirst actuator186 is coupled with thefirst connection port142 of thehub connector108 for inflating theballoon112 at the distal end of theinstrument100. In one embodiment, thefirst actuator186 is a syringe having abarrel188 with atip190 that is insertable into thefirst connection port142 and held in place by aLuer connector192. The first actuator includes aplunger194 that is depressible into thebarrel188 for forcing fluid through thetip190 and into thefirst conduit140 extending between theouter shaft106 and theinner shaft124.FIG. 7A shows theplunger194 is an extended position, with theballoon112 in a deflated state.

FIGS. 8A and 8B show theinstrument100 with theplunger194 of thefirst actuator186 in a compressed position for inflating theinflatable balloon112. As the balloon is inflated, the leadingface196 of theballoon112 initially forces the hemostat from the barbs. As theballoon112 is further inflated to the state shown inFIGS. 8A,8B, and9, the leadingface196 of the balloon preferably becomes flatter to provide a larger surface area for applying tamponade pressure to thehemostat200 delivered by theinstrument100. In one embodiment, theballoon112 is preferably transparent so that medical personnel may observe the hemostat through the walls of the inflated balloon.

As shown inFIG. 9, the inverted configuration of thedistal end152 of theballoon112, and the attachment of the inverteddistal end152 to thedistal end148 of theinner shaft124, results in the leadingface196 of the inflated balloon projecting distally of thedistal end148 of theinner shaft124. This results in theinflated balloon112 forming the distal-most position of theinstrument100 for engaging the hemostat. The attachment configuration also provides aballoon112 having a flatterleading face196 than would be possible with a balloon that does not invert the distal end.

Referring toFIGS. 10A and 10B, in one embodiment of the invention, all of the elements shown and described above remain the same except that the stylet ofFIGS. 4A-4C is replaced by asecond actuator1210 that carries a flowable material such as a flowable hemostat or a flowable sealant. In one embodiment, thesecond actuator1210 is a syringe including abarrel1212 having adispensing tip1214 and aLuer connector1216 that surrounds thetip1214. The Luer connector desirably includesinternal threads1218 that are adapted to engage theouter threads146 of thesecond connection port144 of the hub connector108 (FIG. 2). Thesecond actuator1210 preferably includes aplunger1220 that is depressible for forcing the flowable material through thedispensing tip1214 and into the central lumen of the inner shaft so as to dispense the flowable material from the distal end of the instrument. The inflated balloon may then be used to press the flowable material onto the tissue at the surgical site.

In another embodiment, the second actuator includes a sealant dispensing system such as the system sold under the trademark EVICEL™ by Johnson & Johnson of New Brunswick, N.J. The sealant dispensing system may include one or more catheters that are inserted through the central lumen of the inner shaft so that the dispensing ends of the one or more catheters are located at the distal end of the inner shaft. The sealant dispensing system may include one or more syringes and a Luer connector for coupling to the hub connector.

FIGS. 11A and 11B show thesecond actuator1210 secured to thesecond connection port144 of thehub connector108. Thedispensing tip1214 is positioned in communication with thecentral lumen160 of the inner shaft so that flowable material contained within the chamber of thebarrel1212 may be dispensed into the central lumen for advancement to the distal end of thecentral lumen160.

FIGS. 12A and 12B show theinstrument100 having thefirst actuator186 coupled with the first connection port of thehub connector108, and thesecond actuator1210 coupled with the second connection port of thehub connector108. InFIGS. 12A and 12B, theplunger194 of thefirst actuator186 has been depressed for inflating theinflatable balloon112. Theplunger1220 of thesecond actuator1210 may also be depressed for dispensing the flowable material from thebarrel1212 and into thecentral lumen160 of the inner shaft. In one embodiment, theballoon112 is inflated before the flowable material is dispensed from the second actuator. In a second embodiment, the flowable material is dispensed before the balloon is inflated. In another embodiment, the balloon may be inflated at the same time, or around the same time, that the flowable material is being dispensed from the second actuator. In still other embodiments, the exact order for inflating the balloon and dispensing the flowable material may change.

Referring toFIGS. 13A and 13B, in one embodiment, aninstrument2100 for controlling bleeding includes ahandle2108 that replaces thehub connector108 shown and described above. Thehandle2108 has a vertically extendingtrigger portion2115 that includes afirst connection port2142 for receiving afirst actuator2186, and a horizontally extendingsection2125 that includes asecond connection port2144 adapted to receive astylet2164. In one embodiment, thehandle2108 has all of the features shown and described above for thehub connector108. Thehandle2108 preferably has an ergonomic design that enables it to be more easily grasped by an operator during a surgical procedure. In operation, the barbs at the distal end of thestylet2164 are adapted to hold a hemostat. Thefirst actuator2186 may be operated for selectively inflating theinflatable balloon2112.

Referring toFIGS. 14A and 14B, in one embodiment, thestylet2164 ofFIGS. 13A and 13B is replaced by asecond actuator2210 containing a flowable material. In one embodiment, the dispensing tip of the second actuator is inserted into thesecond connection port2144 of thehandle2108. Theplunger2220 of thesecond actuator2210 is depressible for discharging the flowable material from thesecond actuator2210 and into thecentral lumen2160 of the inner shaft. The flowable material is preferably discharged from thedistal end2104 of theinstrument2100 and tamped onto the tissue at a surgical site by the leadingface2196 of theinflated balloon2112.

Referring toFIG. 15, in one embodiment, aninstrument3100 for controlling bleeding has a proximal end3102, adistal end3104, and ashaft3106 that extends between the proximal and distal ends. The instrument includes ahub connector3108 coupled with aproximal end3110 of the shaft and aninflatable balloon3112 coupled with adistal end3114 of the shaft.

Referring toFIGS. 16A and 16B, thehub connector3108 is secured to theproximal end3110 of theshaft3106. Referring toFIG. 16B, thehub connector3108 includes ashaft support tube3126 having acentral bore3128 that extends between aleading end3130 and a trailingend3132 of the shaft support tube. Thecentral bore3128 has an inner diameter that closely matches the outer diameter of theshaft3106. Thehub connector108 desirably includes aconnection port3144 adjacent the trailingend3132 of theshaft support tube3126.Threads3146 are provided around the trailingend3132 of theshaft support tube3126 to provide a threaded coupling for an opposing element, such as a Luer connector, as will be described in more detail below. Theshaft3106 desirably has acentral lumen3155 that extends from the proximal end to the distal end of theshaft3106. Thecentral lumen3155 is preferably in communication with theconnection port3144 at the trailing end of thehub connector3108. AlthoughFIG. 16B shows an embodiment whereby theconnection port3144 is aligned with the central lumen, in other embodiments it is contemplated that theconnection port3144 may be provided at a wide range of orientations relative to thecentral lumen3155 and still fall within the scope of the present invention.

Referring toFIGS. 17 and 18, in one embodiment anactuator3186 is coupled with theconnection port3144 of thehub connector3108 for inflating theballoon3112 at thedistal end3114 of theshaft3106. Theactuator3186 desirably includes a syringe having a barrel3188 with atip190 that is insertable into theconnection port3144 and held in place by a Luer connector3192 having internal threads that engage thethreads3146 around theconnection port3144. The actuator includes aplunger3194 that is depressible into the barrel3188 for forcing fluid through the tip3190 and into thecentral lumen3155 of theshaft3106.

Referring toFIGS. 19A and 19B, in one embodiment, thedistal end3104 of theinstrument3100 includes theshaft3106 and thecentral lumen3155 that extends to the distal end of the shaft. As shown inFIG. 19B, an opening at the distal end of theshaft3106 is sealed by aplug3172 that forms an air-tight seal at the distal end of the shaft. Theinstrument3100 includes theinflatable balloon3112 having aproximal end3150 secured to theshaft3106, and adistal end3152 that is secured to thedistal end3114 of theshaft3106. Thedistal end3152 of theballoon3112 is preferably secured to a more distal section of the shaft than theproximal end3150 of theballoon3112. Thedistal end3152 of theinflatable balloon3112 is preferably inverted, and the inverted distal end is preferably secured to an outer surface of theshaft3106 at the distal end of the shaft. The above-described structure forms an air-tight compartment3154 inside theinflatable balloon3112. The distal end of thecentral lumen3155 is preferably in communication with thecompartment3154 through aninlet opening3140 extending though the outer wall of theshaft3106. In one embodiment, fluid such as air may be directed through thecentral lumen3155, theinlet opening3140, and into thecompartment3154 for inflating theballoon3112. When it is desirable to deflate theballoon3112, the fluid may be removed from the balloon through theinlet opening3140.

FIG. 20 shows theinstrument3100 with theplunger3194 of theactuator3186 in a compressed position for inflating theinflatable balloon3112. As the balloon is inflated, the leadingface3196 of theballoon3112 may force a hemostat away from the distal end of the instrument. When theballoon3112 is inflated to the state shown inFIG. 21, the leadingface3196 of theballoon3112 provides a flatter surface area that is preferably used to apply tamponade pressure to thehemostat3200 delivered by theinstrument100. Theballoon3112 is preferably transparent so that medical personnel may observe the hemostat through the walls of the inflated balloon.

As shown inFIG. 21, the inverted configuration of thedistal end3152 of theballoon3112, and the attachment of the inverteddistal end3152 to thedistal end3114 of theshaft3106, results in the leadingface3196 of the inflated balloon projecting distally of thedistal-most end3114 of theshaft3106. This results in theinflated balloon3112 forming the distal-most extent of theinstrument3100. The leading face of the balloon may be used to apply pressure to a hemostat or a flowable hemostat material.

Referring toFIGS. 22A and 22B, in one embodiment, theplug4172 at thedistal end4114 of theshaft4106 includes hook-like barbs4176 that project from the distal end of the plug. Thebarbs4176 are preferably adapted to secure a hemostat to the distal end of the instrument. The barbs preferably hold the hemostat to the distal end of the instrument for delivering, deploying and tamponading a hemostat at a surgical site.

Referring toFIG. 23, as theballoon4112 is inflated, the leadingface4196 of theballoon4112 initially forces thehemostat4200 from thebarbs4176. As theballoon4112 is further inflated to the state shown inFIG. 23, the leadingface4196 provides a flat, large surface area that is preferably used to apply tamponade pressure to thehemostat4200 delivered by theinstrument4100. In one embodiment, theballoon4112 is preferably transparent so that medical personnel may observe thehemostat4200 through the walls of the inflated balloon so as to monitor bleeding at the surgical site.

Referring toFIGS. 24 and 25, in one embodiment, aninstrument5100 for controlling bleeding includes ahandle5108 that replaces thehub connector3108 shown and described above in the embodiment ofFIG. 18. Thehandle5108 has a vertically extending trigger-grip portion5115, and a horizontally extendingsection5125 that includes aconnection port5144 that is adapted to receive an actuator for inflating theinflatable balloon5112. In one embodiment, thehandle5108 has all of the features shown and described above for thehub connector3108 ofFIG. 18. Thehandle5108 preferably has an ergonomic design that enables it to be more easily grasped by an operator during a surgical procedure.

Referring toFIGS. 26 and 27, anactuator5186 is coupled with thehandle5108. Theactuator5186 desirably includes a syringe having abarrel5188 with atip5190 that is insertable into theconnection port5144. In one embodiment, thetip5190 is held in place by a Luer connector having internal threads that engage threads around theconnection port5144. The actuator includes aplunger5194 that is depressible into thebarrel5188 for forcing fluid, such as air, through thetip5190 and into the central lumen5155 of theouter shaft5106. As the fluid is forced through the central lumen toward the distal end of theinstrument5100, theballoon5112 is inflated as shown inFIG. 27.

Referring toFIGS. 28A and 28B, in one embodiment, aninstrument6100 for controlling bleeding includes anouter shaft6106 and aninner shaft6124 that is telescopically received in the outer shaft. As will be described in more detail below, the outer and inner shafts move relative to one another for altering the shape of aninflated balloon6112. Theinstrument6100 includes theouter shaft6106 having adistal end6114, and theinner shaft6124 extending beyond the distal end of theouter shaft6106. The inner shaft includes acentral lumen6160 that extends to the distal end thereof, and aninlet opening6140 extending through the outer wall of the inner shaft. An opening at the distal-most end of the inner shaft is closed by aplug6172 that forms an air-tight seal at the distal end of the inner shaft.

Theinstrument6100 includes theinflatable balloon6112 having aproximal end6150 that is secured to an outer surface of theouter shaft6106, and adistal end6152 that is secured to the distal end of theinner shaft6124. The distal end of the balloon is preferably inverted before it is secured to the inner shaft. Referring toFIG. 29, theballoon6112 may be inflated by directing fluid through thecentral lumen6160 of theinner shaft6124, through theinlet opening6140, and into theballoon6112. The shape of the balloon may be changed from the more spherical shape shown inFIG. 29 to the more toroidal shape shown inFIG. 30. In one embodiment, the shape of the balloon is changed by moving theouter shaft6106 in the direction Al relative to the inner shaft. As the shape of the balloon changes, the leading face6196 of the balloon flattens to provide a larger surface area at the distal-most end of the instrument for applying pressure to a hemostat at a surgical site.

Referring toFIGS. 31A and 31B, in one embodiment, aninstrument7100 for controlling bleeding includes aplug7172 that forms an air-tight seal at a distal end of aninner shaft7124. Theplug7172 includes hook-like barbs7176 that are adapted to hold a hemostat at the distal end of the instrument. The instrument includes aninflatable balloon7112 having aproximal end7150 secured to a distal end of anouter shaft7106 and adistal end7152 that is inverted, with the inverted distal end being secured to the distal end of theinner shaft7124. Referring toFIG. 31B, theouter shaft7106 is movable in a distal direction A2 relative to theinner shaft7124.

Referring toFIG. 32, theinflatable balloon7112 may be inflated using one of the actuators described herein. When the balloon is initially inflated, it has the spherical shape shown inFIG. 32. Theouter shaft7106 may then be moved distally relative to theinner shaft7124 to provide theballoon7112 with a more toroidal shape as shown inFIG. 33. The leading face7196 of the balloon has a larger, flatter surface area for applying pressure to a hemostat at a surgical site.

In one embodiment, the present invention enables the shape of an inflated balloon to be changed so as to maximize the surface area available for selectively applying tamponade pressure to a medical patch. Thus, the present invention enables an increased balloon surface area to be applied to a medical patch. This may be particularly useful for applying pressure on hemostatic dressings, flowable hemostats, and flowable sealants.

Referring toFIG. 34, in one embodiment, a distal end of aninstrument8100 for controlling bleeding includes theouter shaft8106, aninner shaft8124, and afirst conduit8140 that extends between the outer and inner shafts. A distal end8148 of the inner shaft preferably extends beyond thedistal end8114 of theouter shaft8106. The instrument includes aninflatable balloon8112 having aproximal end8150 secured to thedistal end8114 of theouter shaft8106, and adistal end8152 that is secured to the distal end8148 of theinner shaft8124. Theproximal end8150 of theinflatable balloon8112 is preferably secured to an outer surface of theouter shaft8106. Thedistal end8152 of theinflatable balloon8112 is preferably inverted, and the inverted distal end is preferably secured to an outer surface of theinner shaft8124 at the distal end8148 of theinner shaft8124. The above-described structure desirably forms an air-tight compartment8154 inside theinflatable balloon8112. Thedistal end8156 of thefirst conduit8140 is preferably in communication with the air-tight compartment8154. Fluid such as air may be directed through thefirst conduit8140 and into thecompartment8154 for inflating theballoon8112. When it is desirable to deflate theballoon8112, the fluid may be removed from the balloon through thefirst conduit8140. In the particular embodiment shown inFIG. 34, the outer andinner shafts8106,8124 move relative to one another for changing the shape of theballoon8112. In one preferred embodiment, after theballoon8112 is inflated, theouter shaft8106 moves in the distal direction A3 relative to theinner shaft8124 for changing the shape of the balloon.

Theinner shaft8124 has acentral lumen8160 that defines adistal opening8163 at the distal end8148 of the inner shaft. As will be described in more detail below, in one embodiment a stylet is passable through thecentral lumen8160 so that a distal end of the stylet extends from thedistal opening8163 at the distal end of theinstrument8100. The stylet may be used to secure a medical textile such as a hemostat at the distal end of the instrument. In another embodiment, a flowable material such as a flowable hemostat material may pass through the central lumen and be dispensed from thedistal opening8163 at the distal end of thecentral lumen8160. In still another embodiment, a sealant dispensing system may be inserted into thecentral lumen8160 such as by inserting the catheter of the sealant dispensing system through thecentral lumen8160.

FIG. 35A shows theouter shaft8106 in a retracted position relative to theinner shaft8124, thereby providing theinflated balloon8112 with a spherical shape. InFIG. 35B, theouter shaft8106 has been moved in a distal direction A3 relative to theinner shaft8124, thereby changing the shape of the balloon. In one embodiment, the balloon changes into a toroidal shape having a flatterleading face8196. The flatterleading face8196 provides a larger surface area for applying tamponade pressure to a hemostat or a sealant. As noted above, thecentral lumen8160 extending to the distal end of theinner shaft8124 enables a stylet or a flowable material to be passed through thedistal opening8163 at the distal end of thecentral lumen8160.

Referring toFIGS. 36A and 36B, in one embodiment, aninstrument8100 for controlling bleeding may combine one or more of the features disclosed in the above embodiments with the moveable outer shaft embodiment of FIGS.34 and35A-35B. In one embodiment, the instrument includes ahandle8108, and afirst actuator8186 coupled with the handle. Thefirst actuator8186 has aplunger8194 that is depressible for inflating aninflatable balloon8112. Theinstrument8100 also includes a second connection port that is aligned with the central lumen that extends through the inner shaft. The second connection port is adapted to receive astylet8164. The distal end of thestylet8164 may include barbs for holding a hemostat at the distal end of the stylet. Theinstrument8100 also preferably includes ashaft actuator8155 for moving theouter shaft8106 relative to the inner shaft. InFIG. 36A, theshaft actuator8155 is in a first position whereby the outer shaft is retracted relative to the inner shaft. InFIG. 36B theshaft actuator8155 has been moved to a second position for moving the outer shaft distally relative to the inner shaft to change the shape of theinflated balloon8112.

FIGS. 37A and 37B show another embodiment of the present invention whereby thestylet8164 is removed from the second connection port and replaced by asecond actuator8210 containing a flowable material. Thesecond actuator8210 may include a syringe having a barrel containing a flowable hemostat material and adepressible plunger8220 for dispensing the flowable hemostat material from the barrel. In one embodiment, thesecond actuator8210 may include a sealant dispensing system having one or more syringes containing a sealant and a catheter that is extendable through the central lumen of the inner shaft. As in the above embodiment, the instrument includes ahandle8108 having thefirst actuator8186 with adepressible plunger8194 for inflating theballoon8112. Theinstrument8100 includes ashaft actuator8155 movable between first and second positions for moving theouter shaft8106 relative to the inner shaft for changing the shape of theballoon8112.

Although various embodiments of the present invention have been disclosed herein, it is contemplated that other embodiments may combine one or more features of any one of the embodiments and still fall within the scope of the present invention. One embodiment of the present invention may incorporate one or more of the features or method steps disclosed in commonly assigned U.S. patent application Ser. No. 12/049,849, entitled “APPLICATOR INSTRUMENTS FOR THE DELIVERY, DEPLOYMENT, AND TAMPONADE OF HEMOSTATS AND METHODS THEREFOR,” filed Mar. 17, 2008, and U.S. patent application Ser. No. 12/049,869, entitled “APPLICATOR INSTRUMENTS HAVING PROTECTIVE CARRIERS FOR HEMOSTATS AND METHODS THEREFOR,” filed Mar. 17, 2008, the disclosures of which are hereby incorporated by reference herein.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof.

Claims (26)

1. An instrument for controlling bleeding comprising:

a rigid outer shaft having a proximal end, a distal end, and a central lumen extending between the proximal and distal ends;

a rigid inner shaft disposed within the central lumen of said outer shaft, said inner shaft having a proximal end, a distal end that extends beyond the distal end of said outer shaft, and a central lumen extending between the proximal and distal ends thereof;

an inflatable balloon having a proximal end secured to said outer shaft and a distal end that is inverted, wherein said inverted distal end of said balloon is secured to said inner shaft;

a first actuator in communication with said inflatable balloon for selectively inflating said balloon;

a shaft actuator connected with at least one of said shafts for selectively moving said outer and inner shafts relative to one another, wherein upon inflation of said balloon, said shaft actuator is engageable for moving said outer and inner shafts from a first position in which said inflated balloon has a rounder leading face to a second position in which said inflated balloon has a flatter leading face, and wherein said shaft actuator is adapted to hold said outer and inner shafts in the second position for maintaining the shape of said flatter leading face of said inflated balloon as said flatter leading face is used to apply pressure for controlling bleeding; and a hemostat in contact with said inverted distal end of said balloon, wherein as said balloon is inflated said expanding balloon deploys said hemostat in contact with said inverted distal end of said balloon, and wherein said deployed hemostat conforms to said flatter leading face when said outer and inner shafts are in the second position.

2. The instrument as claimed inclaim 1, further comprising a first conduit extending between said inner and outer shafts and toward the distal ends of said inner and outer shafts, wherein the first conduit has a first end in communication with said inflatable balloon and a second end in communication with said first actuator, wherein upon inflation said leading face projects distally of said distal end of said inner shaft for forming a distal-most end of said instrument.

3. The instrument as claimed inclaim 2, further comprising a hub connector secured to the proximal end of said outer shaft, said hub connector having a first connection port for coupling said first actuator with the first conduit.

4. The instrument as claimed inclaim 3, wherein said first actuator comprises a syringe having a barrel and a plunger, and wherein said plunger is depressible for introducing fluid into said balloon.

5. The instrument as claimed inclaim 3, wherein said hub connector further comprises a second connection port that is aligned with the central lumen of said inner shaft.

6. The instrument as claimed inclaim 5, further comprising a stylet having proximal and distal ends, a handle at the proximal end thereof, and hook-like barbs at the distal end thereof, wherein said stylet is insertable into said second connection port and through the central lumen of said inner shaft for positioning the hook-like barbs at the distal end of said inner shaft.

7. The instrument as claimed inclaim 6, wherein said stylet further comprises threads or a tapered surface for securing said stylet to said hub connector.

8. The instrument as claimed inclaim 5, further comprising a second actuator adapted to hold a flowable material, wherein said second actuator is securable to the second connection port of said hub connector.

9. The instrument as claimed inclaim 8, wherein said second actuator comprises one or more barrels for holding said flowable material, one or more discharge openings alignable with the central lumen of said inner shaft, and one or more plungers that are depressible for dispensing said flowable material.

10. The instrument as claimed inclaim 1, wherein said shaft actuator is engageable for selectively moving the distal ends of said shafts relative to one another for changing the shape of said inflatable balloon.

11. The instrument as claimed inclaim 10, wherein said shaft actuator is adapted to selectively move the distal end of said outer shaft in a distal direction relative to the distal end of said inner shaft for changing the shape of said inflatable balloon secured to said outer and inner shafts.

12. The instrument as claimed inclaim 1, wherein said hemostat is selected from the group consisting of medical textiles, flowable hemostats and flowable sealants.

13. An instrument for controlling bleeding comprising:

a single shaft having a proximal end and a distal end;

an inflatable balloon having a proximal end secured to said single shaft and a distal end that is inverted, wherein said inverted distal end of said balloon is secured to the distal end of said single shaft; and

an actuator for selectively inflating said inflatable balloon, wherein upon inflation said inflated balloon has a toroidal shape having a flattened leading face at a distal-most point of said instrument adapted to apply pressure for controlling bleeding; and a hemostat in contact with said inverted distal end of said balloon, wherein as said balloon is inflated said expanding balloon deploys said hemostat in contact with said inverted distal end of said balloon, and wherein said deployed hemostat conforms to said flattened leading face.

14. The instrument as claimed inclaim 13, said instrument further comprising barbs projecting from the distal end of said shaft.

15. The instrument as claimed inclaim 14, wherein said shaft has a longitudinal axis extending between the proximal and distal ends thereof, and said barbs project along the longitudinal axis.

16. The instrument as claimed inclaim 13, wherein the inverted distal end of said inflatable balloon is connected to a distal-most end of said shaft.

17. The instrument as claimed inclaim 13, wherein said actuator for selectively inflating said inflatable balloon is coupled with a connection port located at the proximal end of said shaft.

18. The instrument as claimed inclaim 13, further comprising a valve in communication with said inflatable balloon for selectively deflating said balloon.

19. The instrument as claimed inclaim 13, wherein said hemostat is selected from the group consisting of medical textiles, flowable hemostats and flowable sealants.

20. An instrument for controlling bleeding comprising:

a rigid inner shaft having a proximal end and a distal end;

a rigid outer shaft having a proximal end and a distal end, said outer shaft surrounding said inner shaft;

a first lumen extending between said inner and outer shafts;

a second lumen extending though said inner shaft to a distal opening at the distal end of said inner shaft;

an inflatable balloon secured to the distal end of said instrument, said inflatable balloon being in communication with said first lumen, wherein said balloon has a proximal end secured to said outer shaft and a distal end surrounding the distal opening of said second lumen and being secured to said inner shaft, and wherein the distal end of said balloon is inverted and the inverted distal end of said balloon is secured to the distal end of said inner shaft;

a shaft actuator connected with at least one of said shafts for selectively moving said shafts relative to one another, wherein upon inflation of said balloon, said shaft actuator is engageable for moving said shafts from a first position in which said inflated balloon has a rounder leading face to a second position in which said inflated balloon has a flatter leading face, and wherein said shaft actuator is adapted to hold said shafts in the second position for maintaining the shape of said flatter leading face of said inflated balloon as said flatter leading face is used to apply pressure for controlling bleeding; and a hemostat in contact with said inverted distal end of said balloon, wherein as said balloon is inflated said expanding balloon deploys said hemostat in contact with said inverted distal end of said balloon, and wherein said deployed hemostat conforms to said flatter leading face when said outer and inner shafts are in the second position.

21. The instrument as claimed inclaim 20, further comprising:

a first actuator in communication with said first lumen for selectively inflating said balloon; and

a second actuator in communication with said second lumen for introducing a flowable material into said second lumen for discharging said flowable material from the distal opening at the distal end of said inner shaft.

22. The instrument as claimed inclaim 21, wherein said flowable material is selected from the group consisting of a sealant, and a flowable hemostat material.

23. The instrument as claimed inclaim 22, wherein said first actuator comprises an inflation syringe and said second actuator comprises a syringe filled with the flowable material.

24. The instrument as claimed inclaim 23, further comprising a hub connector secured to the proximal end of said outer shaft, said hub connector including a first connection port in communication with said first lumen and a second connection port in communication with said second lumen, wherein said first actuator is coupled with said first connection port and said second actuator is coupled with said second connection port.

25. The instrument as claimed inclaim 21, wherein said shaft actuator is coupled with said outer shaft for moving the distal end of said outer shaft distally relative to the distal end of said inner shaft.

26. The instrument as claimed inclaim 20, wherein said hemostat is selected from the group consisting of medical textiles, flowable hemostats and flowable sealants.

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